Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination

Pain Clinical Trial

Official title:

Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880125
• Other study ID #: YJ4-101
• Status: Completed
• Phase: Phase 1
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: April 2021
• Source: Yungjin Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state

2. Subjects: Healthy subject

3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.

Description:

This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Subjects between the ages of 20 and 45 years

• Subjects weighed = 45 kg and were within 20% of their ideal body weight

• No clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test

Exclusion Criteria:

• Hypersensitivity or histories of sensitivity to either tramadol or acetaminophen

• Evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases

• Taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study

• Systolic blood pressure (SBP) = 160 mmHg or = 100 mmHg or diastolic blood pressure (DBP) = 95 mmHg or = 60 mmHg

• Any surgical or medical conditions that could affect drug absorption

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Tramadol HCI/Acetaminophen
Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yungjin Pharm. Co., Ltd.	Chonbuk National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state	Bio-equivalence of Cmax at steady state of tramadol and acetaminophen	0 to 36 hour
Primary	Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state	Bio-equivalence of AUC at steady state of tramadol and acetaminophen	0 to 36 hour
Secondary	Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state	Tmax of tramadol and acetaminophen at steady state.	0 to 36 hour
Secondary	Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state	Half-life of tramadol and acetaminophen at steady state.	0 to 36 hour
Secondary	Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state	Accumulation index of tramadol and acetaminophen at steady state.	0 to 36 hour
Secondary	Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state	Cmax of O-desmethyltramadol at steady state	0 to 36 hour
Secondary	Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state	AUC of O-desmethyltramadol at steady state	0 to 36 hour
Secondary	Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state	Tmax of O-desmethyltramadol at steady state	0 to 36 hour
Secondary	Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state	Half-life of O-desmethyltramadol at steady state	0 to 36 hour